Johnson & Johnson shocked the medtech industry early last year when it announced it
would acquire Shockwave Medical
, a specialist in the intravascular lithotripsy (IVL) market.
Shockwave had a huge splash recently at the Transcatheter Cardiovascular Therapeutics conference.
MD+DI
spoke with Nick West Shockwave Medical’s CMO the company’s presence at TCT and the IVL market.
Let’s talk about the IVL market – can we get a sense of how large it is and perhaps the rate at which it’s growing?
West:
At TCT 2025, Shockwave Medical celebrated an incredible milestone in treating one million patients with our innovative IVL technology, demonstrating the impact of our products on physician practice and on the lives of their patients. And it’s important to state that we’re not stopping here.
The market is continuing to grow, and we expect that competition will only increase the focus on calcium management and bring more growth in the years to come.
What new clinical data will Shockwave be presenting at TCT, and how does this data advance our understanding of IVL's effectiveness?
West:
Evidence generation remains a top priority for Shockwave, and at TCT 2025 we are proud that we continued the momentum.
We had 8 company-sponsored and funded studies presented at TCT for both IVL and Reducer that continue to expand our comprehensive portfolio of clinical evidence. Highlights include:
Javelin CAD Early Feasibility Study
showed impressive results in the initial patients with complex coronary disease treated with this novel Forward IVL technology.
EMPOWER CAD OCT sub-analysis
evaluated the use of OCT imaging and IVL use in an all-comers population of women and resulted in successful modification of severely calcified lesions.
Reducer I gender sub-analysis
demonstrated significant improvements in CCS angina class and quality of life, as well as low rates of MACE in women.
No other calcium modification technology has generated the volume and breadth of data that we have, supporting both the efficacy and the safety of Shockwave IVL, and we're not stopping here. Every day, we're continuing to add to the clinical evidence across more than 600 studies and 22,000 patient outcomes.
The consistency of our results across trials and real-world practice is what gives me the utmost confidence in our technology and our innovations to come.
With more than 30 active R&D programs currently underway, what are the key innovation areas Shockwave is focusing on for future IVL development?
West:
Shockwave is focused on continuing to push the boundaries of what is possible, to deliver technology that meets both physician and patient needs. We have an established record of physician-directed innovation, and by listening and learning to their valuable insights, we can apply their feedback to the R&D process and ultimately into our products. For example, driven by unmet clinical need and publications, we have developed a new device designed specifically to treat carotid artery calcification - and that will be entering a clinical trial sometime soon.
What are the biggest technical challenges in developing "first-of-its-kind" innovations in the IVL market, and how does Shockwave overcome them?
West:
First-of-its-kind innovation requires a willingness to think outside of existing features and the ability to understand which requirements are the most important to address. We develop solutions with physicians, for physicians, and for their patients’ unmet needs. By listening, collaborating, and co-creating, we ensure our technology integrates seamlessly into clinical practice and empowers providers to deliver optimal care.
As an example, physicians told us that they needed an IVL platform that could address balloon-uncrossable calcified lesions. In response, we developed the Shockwave Javelin Peripheral IVL Catheter, a novel catheter-based system. This device does not have a balloon but has a single emitter immediately behind the tip of the catheter with a small chamber that acts like the balloon.
The biggest technical challenge was developing an IVL platform that could modify calcium and cross extremely narrowed vessels. We transitioned from our balloon-based IVL platform to the first-of-its-kind Forward IVL platform by substituting the balloon for a miniature fluid-filled window housing our same emitter technology. This single emitter creates up to 120 Shockwaves - or spherical ultrasonic acoustic pressure waves - that extend beyond the tip of the catheter. The Javelin IVL catheter’s design, therefore, allows delivery of lithotripsy closer to occlusive calcific lesions than the balloon-based platform could ever enable.
How is Shockwave positioning itself to maintain market leadership as the IVL space becomes more competitive, and what sets your technology apart from emerging alternatives?
West:
New entrants will propel the calcium modification market forward, providing physicians with more options and the potential for more patients to be treated. We will continue to deliver the most compelling innovations possible to address physicians’ unmet needs and those of their patients. We will continue to leverage our first-mover advantage and keep “moving the goal posts” of what defines best-in-class in both IVL and the broader calcium modification space. We will continue to build our comprehensive evidence base for Shockwave IVL, demonstrating that the acoustic energy-based generation of ultrasonic acoustic pressure waves for modification, fracture, and fragmentation of vascular calcification is both safe and efficacious, and pursue our strategy of relentless iteration and innovation.
Looking ahead, what does the future roadmap for IVL technology look like, and what new applications or patient populations might benefit?
West: As pioneers and market leaders in IVL, our focus is to address unmet clinical needs by delivering an expanding portfolio of innovative therapies that, in turn, will transform the treatment of cardiovascular disease. Our innovation is physician-led: we listen to their pain points and work to address their needs to enable improved patient care.
We plan to launch at least one IVL product every year for the foreseeable future to address different clinical needs and maintain our undisputed leadership in this space. In the last year, we have launched the E8 peripheral IVL catheter, building on our heritage of disruptive endovascular technologies – and in terms of novel devices, we also released the Javelin peripheral IVL catheter, a first-in-class platform with no balloon and a single distally-positioned emitter, designed for the most complex, balloon-uncrossable or occluded lesions. The new, redesigned, and more deliverable version of our C2+ coronary IVL platform will be available next year, and with the FORWARD CAD IDE trial examining the use of the Javelin coronary IVL catheter nearing completion of enrollment, our progress will continue through 2026 and beyond.
With the combination of new technologies and increasing volumes of real-world evidence demonstrating the impact of IVL, we’re confident we will drive towards our next million patients treated.